The invention relates to a tracheostoma valve comprising a main air passage structure provided with a main valve arrangement.
Severe cancer in the laryngeal or hypopharyngeal region often requires a total laryngectomy, i.e. excision of the larynx (including vocal folds). Reconstruction is performed by leading the trachea outside. The trachea then ends in an opening in the neck, the so-called “tracheostoma”. After this operation, voice restoration usually takes place by tracheo-oesophageal puncture and the insertion of a one-way valve (“shunt valve”) in the puncture. In other words, such a shunt valve is inserted in the wall between the trachea and the oesophagus. By closing the tracheostoma (manually or by means of a so-called “tracheostoma valve”), exhalation air flows through the shunt valve to an air chamber enclosed by soft tissue at the top of the oesophagus, which then starts to vibrate and acts as new “vocal folds”.
One of the major problems for the patient who has undergone a laryngectomy and voice rehabilitation concerns the tracheostoma. The tracheostoma attracts attention, especially when the patient has to close it with a thumb or finger in order to speak. Also, stoma closure can be unhygienic and impractical when the patient's hands are dirty. Manual tracheostoma closure is also impossible during certain activities, e.g., while driving a car, eating, or participating in sports. Therefore, several tracheostoma valves have been developed in an attempt to overcome these problems related to manual tracheostoma closure.
Such tracheostoma valves are switchable from a breathing condition into a speaking condition, and vice versa. In the breathing condition the main valve arrangement is in an open position allowing air inhalation and exhalation via the main air passage structure. In the speaking condition the main valve arrangement is in a closed position preventing at least air exhalation via the main air passage structure.
The earliest known tracheostoma valves are of a type in which the tracheostoma valve can be switched, in response to a spurt of exhalation air, from said breathing condition into said speaking condition, while the tracheostoma valve switches back, in response to inhalation, from said speaking condition into said breathing condition. This type of known tracheostoma valves (herein referred to as “exhalation valves”) has several drawbacks, such as the following. A portion of the exhalation air that is needed for bringing the valve in speaking condition can not be used anymore for speech production. When one has to inhale again, the valve changes from speaking condition into breathing condition. For continuation of speech, the valve then has to be brought in speaking condition again. Furthermore, such exhalation valves are expensive and susceptible to maintenance because they consist of many parts. They are difficult to operate (small knobs for setting), large, heavy, conspicious and hard to the touch.
More recently, in an attempt to overcome some of these drawbacks, there has been developed another tracheostoma valve type. For this other type, the tracheostoma valve is switchable, in response to a spurt of inhalation air, from said breathing condition into said speaking condition, while the tracheostoma valve is switchable, in response to a spurt of exhalation air, from said speaking condition into said breathing condition. The advantage of this other type of known tracheostoma valves (herein referred to as “inhalation valves”) is that all exhalation air is available for speech. Moreover, inhalation precedes speaking, which makes speech more natural. Such a known inhalation valve is disclosed in EP1025874.
The inhalation valve known from EP1025874 has a further advantage in that it provides an ability to inhale during phonation, allowing the patient to extend the duration of speech indefinitely. Hence, this known inhalation valve can automatically stay in the speaking condition until the patient deliberately changes it into the breathing condition. The ability to inhale during phonation is realized in that this known inhalation valve comprises a one-way bypass valve member which in said speaking condition allows for air inhalation therethrough, but prevents air exhalation therethrough.
Though the known inhalation valve thus solves some important disadvantages of the exhalation valve, the known inhalation valve still has several drawbacks. For example, it is still expensive and susceptible to maintenance because it consist of many parts, it is still difficult to operate (small knobs for setting), large, heavy, conspicious and hard to the touch.